Funded in part by Inventia Healthcare Ltd., Laila Nutraceuticals
Efficacy and Safety of Ashwagandha Root Extract on Cognitive Functions in Healthy, Stressed Adults: A Randomized, Double-Blind, Placebo-Controlled Study
Gopukumar K, Thanawala S, Somepalli V, Rao TSS, Thamatam VB, Chauhan S
Evidence-based complementary and alternative medicine : eCAM · 54 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- Company
- Inventia Healthcare Ltd.
- Company
- Laila Nutraceuticals
- Authors
- At least one author declares a financial tie to industry
Based on 2 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2021-11-30 · Evid Based Complement Alternat Med · vol. 2021 · pp. 1–10
- Publisher
- Hindawi Publishing Corporation
- Cited
- 95 citations · more than 99% of similar papers · 12.6× the field average
- Impact
- Top 10% most cited in its field
- References
- 34 works
- Access
- Open access (hybrid journal) · CC-BY
- Research areas
- Phytochemicals and Medicinal Plants · Medicinal Plants and Neuroprotection · Pharmacology and Nanomedicine Research
- Keywords
- Withania somnifera, Placebo, Medicine, Perceived Stress Scale, Cambridge Neuropsychological Test Automated Battery, Pittsburgh Sleep Quality Index, Randomized controlled trial, Cognition, Internal medicine, Physical therapy, Psychiatry, Spatial memory, Working memory, Sleep quality, Stress (linguistics)
6 authors
From IN
- Gopukumar KumarpillaiBangalore Diabetes Centre
- Shefali Thanawala · correspondingInventia (India)
- Somepalli VenkateswarluLaila Impex (India)
- Tejas Rao
- Vijaya Bhaskar Thamatam
- Sanjaya Chauhan
Abstract
Background
The global prevalence of stress is increasing. Stress adversely affects cognitive ability, sleep quality, and overall psychological well-being. Ashwagandha (Withania somnifera (L.) Dunal), an essential medicine in Ayurveda, is reportedly beneficial in reducing stress and improving memory. This double-blind, randomized, placebo-controlled clinical study evaluated the effect of Ashwagandha root extract sustained-release capsule 300 mg (Prolanza™; hereafter Ashwagandha SR) on cognitive functions, stress levels, sleep quality, overall well-being, and safety in stressed subjects.
Methods
Subjects (130 healthy cognitively sound adults [20-55 years, body mass index:18-29 kg/m2]) having a Perceived Stress Scale (PSS) score of 14-24 were randomized to receive either Ashwagandha SR or placebo. Subjects took one capsule of Ashwagandha SR or placebo daily for 90 consecutive days. This study was registered on Clinical Trials Registry-India (CTRI) on 13/11/2019 [number: CTRI/2019/11/021990]. The primary endpoint was the change in cognitive function as measured by CANTAB from baseline to the end of the study period (90 ± 7 days). The secondary outcomes included the change in PSS-10 score, serum cortisol level (9-11 am), the OHQ score, the PSQI, and serum BDNF levels.
Results
Only 125 completed the study and were evaluated. The Cambridge Neuropsychological Test Automated Battery (CANTAB) reported significantly improved recall memory, and the total error rate in recalling patterns significantly decreased at visit 4 in the Ashwagandha SR group vs. the placebo group (first attempt memory score:12.9 ± 6.7 vs. 10.1 ± 6.3; total errors:17.5 ± 23.3 vs. 27.7 ± 23.6). At visit 4, lower PSS-10 score (13.0 ± 5.0 vs. 18.7 ± 4.6; p p=0.0443), and Pittsburgh Sleep Quality Index (PSQI) score (p p < .0001) were seen in Ashwagandha SR vs. the placebo group, suggesting significantly lower stress levels and significantly better psychological well-being and sleep quality in the former. No adverse events were reported.
Conclusions
This is the first clinical study assessing Ashwagandha SR for its safety and efficacy. Treatment with one Ashwagandha SR capsule once daily for 90 days improved memory and focus, psychological well-being, and sleep quality, reduced stress levels, and was safe and well-tolerated.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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